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BACKGROUND: Studies have examined the extent to which public policies such as the Best Pharmaceuticals for Children Act have increased pediatric information in drug labeling. Little attention has focused on pediatric labeling of biologics. This analysis examines the extent to which biologics are labeled for pediatric use or have been studied in children. METHODS: The analysis covers the 96 biologics (excluding vaccines) that were first licensed by the Food and Drug Administration between 1997 and 2010 and were still marketed as of 2010. Product labeling was consulted for information on approved pediatric uses, pediatric studies, or pediatric safety warnings based on analyses of adverse events. The online database ClinicalTrials.gov was searched for registered pediatric studies of these biologics. A separate analysis examined labeling and studies for 55 vaccines. RESULTS: For ∼60% of the 96 biologics, labeling shows approved pediatric use or pediatric study information or both. Approximately 85% of the biologics have ≥1 registered pediatric trial completed, underway, or planned. Overall, ∼90% are labeled for pediatric use, have pediatric information in the label, have a registered pediatric study, or have some combination of these characteristics. For the 55 analyzed vaccines, the corresponding figure is 95%. CONCLUSIONS: A majority of biologics approved in the past 15 years include some pediatric information in their labeling, and pediatric trials have been registered for a substantial majority of these products.

Joan M. Teno, MD, MS, Marilyn J. Field, PhD, and Ira Byock, MD Department of Community Health and Medicine (J.M.T.) and Center for Gerontology and Health Care Research (J.M.T.), Brown Medical School, Providence, Rhode Island; Institute of Medicine (M.J.F.), Washington, DC; and Department of Philosophy (I.B.), University of Montana, and the Program Promoting Excellence in End-of-Life Care (I.B.), Missoula, Montana, USA

Background Periodically, Congress considers expanding Medicare coverage to include some currently excluded health care services. In 1999 and 2000, an Institute of Medicine committee studied the issues related to coverage for certain services, including “medically necessary dental services.” Methods The committee conducted a literature search for dental care studies in five areas: head and neck cancer, leukemia, lymphoma, organ transplantation, and heart valve repair or replacement. The committee examined evidence to support Medicare coverage for dental services related to these conditions and estimated the cost to Medicare of such coverage. Results Evidence supported Medicare coverage for preventive dental care before jaw radiation therapy for head or neck cancer and coverage for treatment to prevent or eliminate acute oral infections for patients with leukemia before chemotherapy. Insufficient evidence supported dental coverage for patients with lymphoma or organ transplants and for patients who had undergone heart valve repair or replacement. Conclusions The committee suggested that Congress update statutory language to permit Medicare coverage of effective dental services needed in conjunction with surgery, chemotherapy, radiation therapy or pharmacological treatment for life-threatening medical conditions. Practice Implications Dental care is important for members of all age groups. More direct, research-based evidence on the efficacy of medically necessary dental care is needed both to guide treatment and to support Medicare payment policy.

Professional societies, like many other organizations around the world, have recognized the need to use more rigorous processes to ensure that healthcare recommendations are informed by the best available research evidence. This is the fourth of a series of 14 articles prepared to advise guideline developers in respiratory and other disease. It focuses on commercial funding of guidelines and managing conflict of interest effectively in the context of guidelines.In this review, we addressed the following topics and questions. (1) How are clinical practice guidelines funded? (2) What are the risks associated with commercial sponsorship of guidelines? (3) What relationships should guideline committee members be required to disclose? (4) What is the most efficient way to obtain complete and accurate disclosures? (5) How should disclosures be publicly shared? (6) When do relationships require management? (7) How should individual conflicts of interest be managed? (8) How could conflict of interest policies be enforced? The literature review included a search of PubMed and other databases for existing systematic reviews and relevant methodological research. Our conclusions are based on available evidence, consideration of what guideline developers are doing, and workshop discussions.Professional societies often depend on industry funding to support clinical practice guideline development. In addition, members of guideline committees frequently have financial relationships with commercial entities, are invested in their intellectual work, or have conflicts related to clinical revenue streams. No systematic reviews or other rigorous evidence regarding best practices for funding models, disclosure mechanisms, management strategies, or enforcement presently exist, but the panel drew several conclusions that could improve transparency and process.

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Objective. The purpose of this article was to highlight the recent call for an evidence-based approach to public policy decision making with respect to funding dental services and the need this creates for enhanced clinical research activities. Study Design. Systematic reviews on topics of importance to oral health care practitioners are being conducted and published by various national and international groups. Recent activities to assess evidence to support medically necessary dental services were reviewed. Results. An Institute of Medicine Committee on Medicare Coverage Extensions found little published scientific evidence that directly assessed the effectiveness of dental services in preventing or managing systemic health outcomes for patients with head and neck cancer, lymphoma, leukemia, organ transplantation, and heart valve repair or replacement. Conclusions. The scientific community must strive to meet the challenge of conducting well-designed randomized, controlled trials that test the impact of dental treatment interventions on systemic health to meet the growing need for evidence to support or refute widely accepted dental treatment protocols for medically complex patients.(Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2001;92:272-5)

Caring for patients at the end of life presents a series of quality-of-care problems to the health care system. In the past, concern has focused on overaggressive treatment of dying patients. Given rapid changes in the financing and delivery of care, it is time to focus on a range of quality problems and address ways to improve care and achieve outcomes desired by patients and their families. We provide a framework for conceptualizing such a task. This article addresses the purposes of measurement, definition of the patient population, timing of measurement, use of surrogates in measurement, scope of services to be evaluated, and the choice of measures. It emphasizes the necessary links between quality measurement and quality improvement.

Telemedicine--the use of information and telecommunications technologies to provide and support health care when distance separates the participants--is receiving increasing attention not only in remote areas where health care access is troublesome but also in urban and suburban locations. Yet the benefits and costs of this blend of medicine and digital technologies must be better demonstrated before today's cautious decisionmakers invest significant funds in its development. Telemedicine presents a framework for evaluating patient care applications of telemedicine. The book identifies managerial, technical, policy, legal, and human factors that must be taken into account in evaluating a telemedicine program. The committee reviews previous efforts to establish evaluation frameworks and reports on results from several completed studies of image transmission, consulting from remote locations, and other telemedicine programs. The committee also examines basic elements of an evaluation and considers relevant issues of quality, accessibility, and cost of health care. Telemedicine will be of immediate interest to anyone with interest in the clinical application of telemedicine.

Today's dental schools confront an environment in higher education and health care that promises less stable financing and, thus, more uncertainty for faculty, students, researchers and administrators. A new report from the Institute of Medicine underscores the need for changes in dental education to prepare for a future that will in many important ways be quite different from the past.

Local adaptation of national guidelines appears to be widespread, but it is little examined in terms of its extent, appropriateness, and impact. But the worst situation for patient and practitioner would be when a good national guideline exists but a bad local guideline guides practice.

This book establishes a framework for assessing health care reform proposals and their implementation. It helps clarify objectives, identifies issues to be addressed in proposals, distinguishes between short- and long-term expectations and achievements, and directs attention to important but sometimes neglected questions about the organization and provision of health care services. In addition, the volume presents a discussion and analysis of issues essential to achieving fundamental goals of health care reform: to maintain and improve health and well-being, to make basic health coverage universal, and to encourage the efficient use of limited resources. The book is a useful resource for anyone developing or assessing options for reform.

Guidelines for the clinical practice of medicine have been proposed as the solution to the whole range of current health care problems. This new book presents the first balanced and highly practical view of guidelines--their strengths, their limitations, and how they can be used most effectively to benefit health care.The volume offers Recommendations and a proposed framework for strengthening development and use of guidelines. Numerous examples of guidelines. A ready-to-use instrument for assessing the soundness of guidelines. Six case studies exploring issues involved when practitioners use guidelines on a daily basis. With a real-world outlook, the volume reviews efforts by agencies and organizations to disseminate guidelines and examines how well guidelines are functioning--exploring issues such as patient information, liability, costs, computerization, and the adaptation of national guidelines to local needs.

To examine the state of the art in the field of medical practice guidelines, to identify limitations, and to suggest future directions.Informal descriptive survey using a questionnaire administered by telephone, supplemented by comments, by opinions, and by examples solicited from the participating organizations.Eight prominent organizations representing prototypic approaches to guideline development; these organizations included three medical societies, two health care organizations, two insurers, and one private health benefits management company.Improving the quality of medical care was a stated goal of all eight surveyed organizations. However, their objectives have not been stated in operational terms, reflecting the lesser emphasis placed on methods and means for both implementing guidelines and evaluating their impact on health practices and outcomes. In contrast, several systematic methods for developing guidelines exist. They differ in the stress placed on formal literature reviews, reliance on local as opposed to national experts, and formal methods of group judgment, but no evidence exists on which approaches produce sounder and more usable guidelines.Guidelines are being vigorously promoted as a means to improve the effectiveness of the health care system. Current initiatives show both strengths and weaknesses. In particular, the attention now paid to the development of guidelines needs to be matched by attention to implementation strategies and to the scientific evaluation of their effectiveness in real clinical settings. Also, more agreement is needed on acceptable methods for developing guidelines, assessing their content, and evaluating their impact on professional behavior, patient outcomes, and health care costs. Fortunately, several initiatives to bring greater order and quality to this field are under way.

Each year, advances in biomedical science save the lives of tens of thousands of children worldwide, prevent or limit disease or disability in many more, and improve the quality of life for countless others. Still, pediatricians and others have long argued that infants, children, and adolescents have not shared equally with adults in biomedical progress. In particular, many drugs that are prescribed for children have not been tested with children. This gap puts them at risk for dosing miscalculations and preventable harms related to metabolic and other differences between children and adults.

The United States is unique among economically advanced nations in its reliance on employers to provide health benefits voluntarily for workers and their families. Although it is well known that this system fails to reach millions of these individuals as well as others who have no connection to the work place, the system has other weaknesses. It also has many advantages. Because most proposals for health care reform assume some continued role for employers, this book makes an important contribution by describing the strength and limitations of the current system of employment-based health benefits. It provides the data and analysis needed to understand the historical, social, and economic dynamics that have shaped present-day arrangements and outlines what might be done to overcome some of the access, value, and equity problems associated with current employer, insurer, and government policies and practices. Health insurance terminology is often perplexing, and this volume defines essential concepts clearly and carefully. Using an array of primary sources, it provides a store of information on who is covered for what services at what costs, on how programs vary by employer size and industry, and on what governments do--and do not do--to oversee employment-based health programs. A case study adapted from real organizations' experiences illustrates some of the practical challenges in designing, managing, and revising benefit programs. The sometimes unintended and unwanted consequences of employer practices for workers and health care providers are explored. Understanding the concepts of risk, biased risk selection, and risk segmentation is fundamental to sound health care reform. This volume thoroughly examines these key concepts and how they complicate efforts to achieve efficiency and equity in health coverage and health care. With health care reform at the forefront of public attention, this volume will be important to policymakers and regulators, employee benefit managers and other executives, trade associations, and decisionmakers in the health insurance industry, as well as analysts, researchers, and students of health policy.

8 hypotheses which seek to account for the continuing variation across nations in policies concerning abortion are tested. Tests of the hypotheses were based on an analysis of quantitative data from 29 developed nations using primarily simple correlations supplemented by some multivariate statistics. In the 22 noncommunist nations Catholicism was found to be a strong conservative influence on abortion policy although leftist political parties at times made independent contributions to the content and timing of policy liberalization. The 7 Communist nations were found as predicted to be more liberal than the non-Communist and Catholicism showed a slight positive association with abortion policy in these 7 countries. Nearly 2/3 of liberal changes in abortion policies occurred under democratic regimes but 4/5 of the conservative changes took place under nondemocratic regimesCommunist or non-Communist. Across all 29 nations regime type and Catholicism together account for about 60% of variation in abortion policies. Since 1972 socioeconomic factors have become more important suggesting the importance over the long run of economic forces affecting fertility-related practices values and policies.

The Hospital Survey and Construction Act of 1946, commonly known as the Hill-Burton Act, was intended to improve the supply, distribution and quality of general hospital beds across the United States. Some also saw the program as a means of affecting the supply and distribution of physicians. The strategy used here for evaluating the Hill-Burton program derives in part from the assumptions about health resources supplies on which Hill-Burton policy was found and in part from a model of socioeconomic convergence developed in public policy research on the American states. Major conclusions include 1) Hill-Burton had a major redistributive impact on state bed supplies; 2) physician redistribution lagged far behind progress in bed redistribution; and 3) interstate distribution of physicians appears to have been unaffected by Hill-Burton-associated bed redistribution, a finding contrary to other work in this area.

Otitis media is one of the most worldwide prevalent diseases that affects children. The socioeconomic costs may exceed 3.5 billion dollars a year in the United States alone in direct and indirect costs. If a vaccine can be developed that will decrease 1% of the illness this would be significant in this country and probably even more valuable in less developed countries.